BACKGROUND: Antipsychotic drugs are associated with adverse effects that can lead to poor medication adherence, stigma, distress and impaired quality of life. AIMS: To review the use of adverse effects of antipsychotic drugs as outcome measures, with a particular emphasis on methodological issues. METHOD: Review of data on adverse effects from sources including randomised controlled trials (RCTs), post-marketing surveillance and naturalistic studies. RESULTS: All have advantages and disadvantages and the best overview comes from considering all sources of data together. Adverse effects are inconsistently reported, hampering cross-study comparisons. Many outcome measures lack clinical meaning. In both naturalistic studies and RCTs adverse effects often account for less treatment discontinuation than lack of efficacy. CONCLUSIONS: Standardisation in the reporting of adverse effects is needed. Patients' subjective experience of medication should be given more consideration. Total discontinuation rates provide a useful global outcome measure that incorporates tolerability and efficacy as well as patient and clinician viewpoints. Patients should be informed of common side-effects prior to treatment and monitored for their occurrence during treatment.
BACKGROUND: Antipsychotic drugs are associated with adverse effects that can lead to poor medication adherence, stigma, distress and impaired quality of life. AIMS: To review the use of adverse effects of antipsychotic drugs as outcome measures, with a particular emphasis on methodological issues. METHOD: Review of data on adverse effects from sources including randomised controlled trials (RCTs), post-marketing surveillance and naturalistic studies. RESULTS: All have advantages and disadvantages and the best overview comes from considering all sources of data together. Adverse effects are inconsistently reported, hampering cross-study comparisons. Many outcome measures lack clinical meaning. In both naturalistic studies and RCTs adverse effects often account for less treatment discontinuation than lack of efficacy. CONCLUSIONS: Standardisation in the reporting of adverse effects is needed. Patients' subjective experience of medication should be given more consideration. Total discontinuation rates provide a useful global outcome measure that incorporates tolerability and efficacy as well as patient and clinician viewpoints. Patients should be informed of common side-effects prior to treatment and monitored for their occurrence during treatment.
Authors: Allen W Nyhuis; Douglas E Faries; Haya Ascher-Svanum; Virginia L Stauffer; Bruce J Kinon Journal: BMC Psychiatry Date: 2010-09-28 Impact factor: 3.630
Authors: Peter M Haddad; W Wolfgang Fleischhacker; Joseph Peuskens; Roberto Cavallaro; Michael Ej Lean; Margarita Morozova; Gavin Reynolds; Jean-Michel Azorin; Pierre Thomas; Hans-Jürgen Möller Journal: Ther Adv Psychopharmacol Date: 2014-02